MAUDE Adverse Event Report: BECTON, DICKINSON & CO. (SPARKS) BD SUREPREP¿ CAPILLARY TUBES- HEPARINIZED; TUBE, COLLECTION, CAPILLARY BLOOD

Catalog Number	420317
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/28/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that while using bd sureprep¿ capillary tubes- heparinized that there was leaking/broken bottle containing patient sample.The following information was provided by the initial reporter: customer states - stocking item end user is stating that the blood is being spill out of the tube.
Additional Manufacturer Narrative
D4.Medical device lot #: unknown.D4.Medical device expiration date: unknown.H4.Device manufacture date: unknown.E.6 initial reporter e-mail: (b)(6).H.3.A device evaluation is anticipated, but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.
Event or Problem Description
It was reported that while using bd sureprep¿ capillary tubes- heparinized that there was leaking/broken bottle containing patient sample.The following information was provided by the initial reporter: customer states - stocking item end user is stating that the blood is being spill out of the tube.
Additional Manufacturer Narrative
Event description: "customer states - stocking item end user is stating that the blood is being spill out of the tube.¿ complaint history review: a review of past complaints on this product over the past 12 months does not indicate a trend on this issue.Device history record review: the review of the device history record could not be performed as no lot number was provided.Sample analysis: no returns or photos were available.An inspection of the retention samples could not be performed as a lot number was not provided.Evaluations results: based on the investigation, no defect was observed.No complaint trend has been observed.Investigation conclusion: based on the evaluation of the investigation, the complaint was not confirmed.No further actions will be taken as no confirmed trend has been identified.However, bd will continue to monitor for trending.

• Brand Name: BD SUREPREP¿ CAPILLARY TUBES- HEPARINIZED
• Common Device Name: TUBE, COLLECTION, CAPILLARY BLOOD
• Manufacturer (Section D): BECTON, DICKINSON & CO. (SPARKS); 7 loveton circle; sparks MD 21152
• Manufacturer (Section G): BECTON, DICKINSON & CO. (SPARKS); 7 loveton circle; sparks MD 21152
• Manufacturer Contact: jennifer suh ; 5859 farinon drive; san antonio, TX 78249 ; 8448235433
• MDR Report Key: 17627442
• Report Number: 1119779-2023-00946
• Device Sequence Number: 6135686
• Product Code: GIO
• UDI-Device Identifier: 30382904203178
• UDI-Public: 30382904203178
• Combination Product (Y/N): N
• Initial Reporter State: MN
• Initial Reporter Country: US
• PMA/510(K) Number: K884623
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 09/07/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Other
• Device Catalogue Number: 420317
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/28/2023
• Supplement Date Received by Manufacturer: 09/07/2023
• Initial Report FDA Received Date: 08/25/2023
• Supplement Report FDA Received Date: 09/15/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown